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A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03606512
Recruitment Status : Active, not recruiting
First Posted : July 31, 2018
Last Update Posted : September 29, 2021
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Biological: Ad26.RSV.preF Biological: Placebo Biological: Nimenrix Phase 1 Phase 2

Detailed Description:
RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Arm Intervention/treatment
Experimental: Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF)
Respiratory syncytial virus (RSV) seronegative toddlers will receive intramuscular (IM) injection of 2.5*10^10 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F-protein on Days 1, 29, and 57.
Biological: Ad26.RSV.preF
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp.
Other Name: JNJ-64400141

Placebo Comparator: Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix)
RSV seronegative toddlers will receive IM injection of placebo on Days 1, 29 and 57. Placebo can be replaced with Nimenrix on Day 57 in countries where applicable.
Biological: Placebo
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.

Biological: Nimenrix
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.

Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after each vaccination (up to Day 64) ]
    Number of participants with solicited local and systemic AEs will be evaluated. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and solicited systemic AEs (fatigue, headache, myalgia, arthralgia, chills, nausea and fever) will be noted in the participant diary after 7 days of each vaccination. Local and systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  2. Number of Participants with Unsolicited AEs [ Time Frame: 28 days after each vaccination (up to Day 85) ]
    Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

  3. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: First vaccination to the end of the study (approximately up to 26 months) ]
    Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

Secondary Outcome Measures :
  1. Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A Strain [ Time Frame: Days 1, 8, 85, and 267 (End of season [EOS]) ]
    RSV neutralizing titers of the vaccine-induced immune response will be assessed for detection of neutralizing antibodies to RSV A strain.

  2. RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Days 1, 8, 85, and 267 (EOS) ]
    Antibodies binding to RSV F-protein in pre-fusion and post-fusion forms will be assessed by enzyme-linked immunosorbent assay (ELISA).

  3. T-Cell Responses Measured by Flow Cytometry (Intracellular cytokine Staining [ICS]) [ Time Frame: Days 1 and 85 ]
    T-cell responses to RSV F-protein peptides for T-helper cells (Th1/Th2) subtyping will be measured by flow cytometry (ICS).

  4. Number of Participants with Severe RSV-Lower Respiratory Tract Infection (LRTI) [ Time Frame: Approximately up to 26 months ]
    Number of participants with severe RSV-LRTI will be assessed. Severe RSV-LRTI will be defined as the presence of severe LRTI as assessed by the Clinical Endpoint Committee (CEC), and confirmation of RSV infection from a nasal (mid-turbinate or nasopharyngeal) sample using reverse transcriptase polymerase chain reaction (RT-PCR).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Participant who is seronegative for respiratory syncytial virus (RSV) within 42 days prior to dosing
  • Participant is the product of a normal term pregnancy greater than or equal to (>=)37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
  • Participant must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
  • Participant has received all routine immunizations appropriate for his or her age according to local guidelines
  • Each participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer

Exclusion Criteria:

  • Participant's weight is below tenth percentile according to World Health Organization (WHO) pediatric growth and weight charts
  • Participant has any clinically significant acute or chronic medical condition (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta 2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness) that, in the opinion of the investigator, would preclude participation
  • Participant is in receipt of, or planning to receive, live attenuated vaccine (for example, measles, mumps and rubella [MMR] or varicella, but excluding rotavirus vaccine) within 28 days of each study vaccination (that is, before and after); other vaccines (for example, influenza, pertussis, polio or rotavirus) should be given at least 14 days before or 14 days after each study vaccination
  • Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
  • Participant has a known allergy to vaccines or vaccine components (including any of the constituents of the study vaccine), or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Participants with egg allergies can be enrolled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03606512

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Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
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Responsible Party: Janssen Vaccines & Prevention B.V. Identifier: NCT03606512    
Other Study ID Numbers: CR108465
2017-003859-36 ( EudraCT Number )
VAC18194RSV2002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes